BRITE TIP 401690MRecalls & reported problems
Cordis US Corp. · SI BRITE TIP F6 90CM · Class 2
All models of BRITE TIP (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000284), received between May 2, 2019 and Jan 5, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Frayed1
- Stretched1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Material Frayed
AS REPORTED, THE DISTAL END OF A 6F 90CM SI BRITE TIP CATHETER SHEATH INTRODUCER WAS FOUND BROKEN/DAMAGED UPON OPENING. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957453 ↗InjuryMay 2, 2019Difficult to Remove; Stretched; Unraveled Material; Difficult to Remove; Stretched; Unraveled Material
AS REPORTED, WHILE TRYING TO REMOVE A BRITE TIP SHEATH (SI BRITE TIP F6 90CM), THE DEVICE BECAME STUCK AND STRETCHED CAUSING EXTREME PAIN. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. THE FOLLOWING DAY, THE PATIENT WAS SAID TO BE FULLY RECOVERED. THE DEVICE WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.
Patient problems: Pain
MAUDE report 8573323 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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